Your Role at Baxter
As a QP & Quality Operation Manager you are creative, thorough, and a heads-down do-er.
You embrace a challenge and apply the collaborative powers of your team to produce great results.
You navigate internal processes to facilitate a product you believe in, absorb and act on complex procedures and data, train your team or peers, and get things done quickly without sacrificing safety or quality.
What you'll be doing
Ensure the compounding site follows Good Manufacturing Practice for Medicinal Products for Human Use.
This is according to Eudralex Volume 4 of "The rules governing medicinal products in the European Union."
Follow Commission Directive *******/EEC, its amendments, and any Baxter company requirements.
Act as a Qualified Person (QP) responsible for implementing the quality management system.
Lead all aspects of the compounded products release process.
Ensure strict adherence to regulatory and customer requirements.
Serve as the primary contact with the regulatory agency (HPRA) regarding Manufacturing Licence, GMP inspections, and any potential compounding product quality issues.
Develop and maintain an internal review process to ensure continuous compliance, preparing the site for audits at any time.
Lead and manage the audit process for the facility, ensuring that audit findings are thoroughly investigated and addressed promptly.
Measure and analyze site quality metrics and indicators, comparing performance against targets, and implement data-driven actions for continuous improvement of processes and products.
Develop and implement risk management strategies to minimize product and process risks, ensuring patient safety.
Coordinate the management, execution, and approval of quality documents and records for the site, including Nonconformance investigations, CAPA plans, Change Controls, SOPs, Validation Protocols, and Reports.
What you'll bring
6-10 years' experience of Quality implementation in Pharma industry
Proven knowledge or experience in applicable regulations and standards e.g. EU GMP Annex 1 particularly in relation to aseptic manufacturing environments.
Proven aseptic manufacture experience with knowledge in Sterility assurance and risk management.
Proven leadership experience with a track record of consistently meeting results.
Ability to operate effectively in a fast-paced environment and prioritize multiple tasks.
Proven ability to manage/supervise a large and diverse team of employees.
Attributes
Strong leadership skills to motivate teams, make decisions and guide the organization toward quality objective.
Excellent organizational skills for managing tasks, coordinating resources, and ensuring prompt quality data driven decision making.
Excellent communication and interpersonal skills to build relationships with collaborators and facilitate collaboration with other Compounding functions.
Benefits
Pension
Competitive package
Health Insurance
Life Assurance and much more.
Equal Employment Opportunity
Baxter is an equal opportunity employer.
Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
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To learn how you can protect yourself, review Recruitment Fraud Notice.
***** Furze Road Sandyford Industrial Estate | Dublin | Co.
Dublin | Ireland
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